Treating Metastatic Pancreatic Cancer Using a New Combination of Chemotherapy Drugs in People with a BRCA1, BRCA2 or PALB2 genetic or tumor mutation (The PLATINUM Trial)
https://www.facingourrisk.org/research-clinical-trials/study/338/treating-metastatic-brca1-brca2-or-palb2-pancreatic-cancer-using-a-new-combination-of-chemotherapy-drugs
Clinicaltrials.gov identifier:
NCT06115499 (https://clinicaltrials.gov/show/NCT06115499)
Treatment
Treatment study for people with metastatic pancreatic cancer and a BRCA1, BRCA2 or PALB2 mutation
Study Contact Information:
For additional information, please contact:
Name: Jamie Crawley, MA
Phone Number:773-702-9934
Email: jcrawley@bsd.uchicago.edu
About the Study
This study will compare a 3-drug chemotherapy combination (NABPLAGEM; gemcitabine, cisplatin, nab-paclitaxel) to a 2-drug chemotherapy combination (gemcitabine/nab-paclitaxel) to treat people with an inherited and/or tumor-associated BRCA1, BRCA2 or PALB2 mutation who have pancreatic cancer that has progressed on front-line treatment with FOLFIRINOX/NALIRIFOX (fluorouracil, irinotecan, leucovorin and oxaliplatin).
What the Study Involves
People enrolled in the study will be randomly assigned to Group 1 or Group 2.
Group 1 (NABPLAGEM): Participants will receive a 3-drug NABPLAGEM chemotherapy combination: gemcitabine, cisplatin, and nab-paclitaxel. This combination will be given intravenously on days 1 and 15 of each cycle. The cycle will repeat every 28 days as long as the cancer does not progress or there are no severe side-effects. Participants will also have MRI or CT scans throughout the trial to determine how the treatment is working. There are also blood sample collections before and after the study so that we can better understand the effects of these treatments.
Group 2 (gemcitabine/nab-paclitaxel): Participants will receive a 2-drug chemotherapy combination: gemcitabine and nab-paclitaxel. This combination will be given on days 1 and 15 of each cycle. The cycle will repeat every 28 days as long as the cancer does not progress or there are no severe side-effects. Participants will also have MRI or CT scans throughout the trial to determine how the treatment is working. There are also blood sample collections before and after the study so that we can better understand the effects of these treatments.
When the study is completed, participants will be followed up within 30 days, and then every 3 months for two years.
This Study is Open To:
People who:
- Are 18 years old or older
- Have metastatic pancreatic cancer
- Have a BRCA1, BRCA2, or PALB2 genetic or tumor mutation
Progressed on first-line FOLFIRINOX/NALIRIFOX for metastatic disease. Previous maintenance treatment with a PARP inhibitor (such as olaparib or rucaparib) is also allowed.
This Study is Not Open To:
People who:
- Are under the age of 18
- Have significant neuropathy from their prior chemotherapy
- Do not have measurable disease on their CT or MRI scans
- Have new or progressive brain metastasis
- Are confined to bed or chair for more than 50% of waking hours.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.